Scheme Description. Clinical Microbiology Laboratory Scheme

Transcription

1 CLS Clinical Microbiology Laboratory Scheme Scheme Description LGC Standards Proficiency Testing 1 Chamberhall Business Park Chamberhall Green Bury Lancashire BL9 0AP United Kingdom Telephone: +44 (0) Fax: +44 (0) ptcustomerservices@lgcgroup.com Website: Issue: 1 Page 1 of 20 Issue date: October 2018

2 Record of issue status and modifications ISSUE ISSUE DATE DETAILS AUTHORISED BY 1 Oct 2018 Version 1 issued. K. Morgan Notes: Where this document has been translated, the English version shall remain the definitive version Issue: 1 Page 2 of 20 Issue date: October 2018

3 Scheme Aims and Organisation The primary aim of the Clinical Microbiology Laboratory proficiency testing scheme (CLS) is to enable laboratories performing the microbiological analysis of clinical samples to monitor their performance and compare it with that of their peers. The CLS scheme also aims to provide information to participants on technical issues and methodologies relating to Clinical Microbiology. The CLS scheme year operates from January to December. Further information about CLS, including test material availability, round despatch dates and reporting deadlines, are available on the current CLS application form. The operation of the scheme is supported by an Advisory Group consisting of experts in the field of Clinical Microbiology. The scheme is run in collaboration with the American Proficiency Institute (API). The scheme reports on the performance of U.K. participants to the National Quality Assurance Advisory Panel for Medical Microbiology. Test Materials Details of test materials available in CLS are given in Appendix A. The test parameters are continually reviewed to ensure they meet the needs of current laboratory testing and regulatory requirements. Note: All test materials provided are intended for use as proficiency testing materials only and are not to be used for any other purposes. Some aspects of the scheme, such as test material production, homogeneity testing and stability assessment, can from time to time be subcontracted. When subcontracting occurs, it is placed with a competent subcontractor and LGC is responsible for this work. The planning of the scheme, the evaluation of performance and the authorisation of the final report will never be subcontracted. Statistical Analysis Information on the statistics used in CLS can be found in the General Protocol and in the Scheme Report. Methods for determining assigned values and the values for SDPA used for individual samples are given in Appendix A. Methods Methods are listed in PORTAL. Please select the most appropriate method from the list. If none of the methods are appropriate, then please report your method as Other and record a brief description in the Comments Section in PORTAL. Results and Reports CLS results are returned through our electronic reporting software, PORTAL, full instructions for which are provided by . However, participants may request result submission forms on which to report and return results if they are unable to report through electronic means. This will incur an additional charge. CLS reports will be available on the website within 10 working days of round closure. Participants will be ed a link to the report when it is available. Issue: 1 Page 3 of 20 Issue date: October 2018

4 APPENDIX A - Description of abbreviations used Assigned Value (AV) The assigned value may be derived in the following ways: From the robust mean (RMean). This is the median of participant results after the removal of test results that are inappropriate for statistical evaluation, e.g. miscalculations, transpositions and other gross errors. Generally, the assigned value will be set using results from all methods, unless the measurement is considered method-dependant, in which case the assigned value will be set by method as illustrated in the report tables. For some analytes, where there is a recognised reference method for that type of measurement, this may be used as the assigned value for a particular analyte i.e. it would be applied to results obtained by any method. Traceability: Assigned values which are derived from the participant results, or a subset of the results are not traceable to an international measurement standard. The uncertainty of assigned values derived in this way is estimated from the participant results, according to ISO From a formulation value (Formulation). This denotes the use of an assigned value derived from sample preparation details, where known and exact quantities of analyte have been used to prepare the sample. Traceability: Assigned values calculated from the formulation of the test sample are traceable, via an unbroken metrological traceability chain, to an international measurement standard. The measurement uncertainty of the assigned value is calculated using the contributions from each calibration in the traceability chain. From a qualitative formulation (Qual Form). This applies to qualitative tests where the assigned value is simply based on the presence/absence of the analyte in the test material. Traceability: Assigned values calculated from the qualitative formulation of the test sample are traceable to a certified reference standard or a microbiological reference strain. From expert labs (Expert). The assigned value for the analyte is provided by an expert laboratory. Traceability: Assigned values provided by an expert laboratory may be traceable to an international measurement standard, according to the laboratory and the method used. The uncertainty of measurement for an assigned value produced in this way will be provided by the laboratory undertaking the analysis. Details of traceability and the associated uncertainty will be provided in the report for the scheme/round. Range This indicates the concentration range at which the analyte may be present in the test material. Issue: 1 Page 4 of 20 Issue date: October 2018

5 SDPA SDPA represents the standard deviation for proficiency assessment which is used to assess participant performance for the measurement of each analyte. Wherever possible, the SDPA is based on a concentration dependent model derived from historic data. Otherwise the SDPA is based upon the RobustSD. Units This indicates the units used for the assessment of data. These are the units in which participants should report their results. For some analytes in some schemes participants may have a choice of which units to report their results, however, the units stipulated in this scheme description are the default units to which any results reported using allowable alternative results will be converted to. DP This indicates the number of decimal places to which participants should report their measurement results. CDM Concentration Dependent Model Issue: 1 Page 5 of 20 Issue date: October 2018

6 Bacteriology Sample BTP Bordetella pertussis/parapertussis - molecular 2 x 1.0ml liquid samples (A and B). Simulated respiratory samples containing chemically modified, non-infectious bacterial cells. Bordetella pertussis Not Detected Bordetella Not parapertussis Detected Sample CDF C. difficile Toxin/Antigen 3 x 1.0ml liquid samples (A, B, and C). Simulated faecal samples containing heat inactivated C. difficile. C. difficile Toxin Antigen or Pos/Neg C. difficile Antigen Antigen Pos/Neg Sample CGC C. trachomatis and N. gonorrhoeae molecular 5 x 1.0ml liquid samples (A, B, C, D, and E). Simulated genital/urinary samples in specimen transport media containing non-infectious bacterial cells. Chlamydia trachomatis Neisseria gonorrhoeae Issue: 1 Page 6 of 20 Issue date: October 2018

7 Sample COM Comprehensive Bacteriology 4 x lyophilized swabs and/or lyophilized pellet in vials with diluent (A, B, C, and D). Simulated patient cultures from various sources containing lyophilized bacteria on swabs and/or a lyophilized pellet with diluent. Blood culture ID Culture isolation and Multi-qualitative Blood culture Antimicrobial susceptibility susceptibility testing Qualitative Qual Form NA NA 0 CSF culture ID Culture isolation and Multi-qualitative CSF culture Antimicrobial susceptibility susceptibility testing Qualitative Qual Form NA NA 0 Ear/Eye culture ID Culture isolation and Multi-qualitative Group B Strep culture Culture isolation and Qualitative N. gonorrhoeae Culture isolation and culture Qualitative Sputum culture ID Culture isolation and Multi-qualitative Sputum culture Antimicrobial susceptibility susceptibility testing Qualitative Qual Form NA NA 0 Stool culture ID Culture isolation and Multi-qualitative Throat culture ID Culture isolation and Multi-qualitative Urine colony count Quantitative culture Qualitative Qual Form NA CFU/mL NA Urine culture ID Urine culture susceptibility Wound culture ID Wound culture susceptibility Culture isolation and Antimicrobial susceptibility testing Culture isolation and Antimicrobial susceptibility testing Multi-qualitative Qualitative Qual Form NA NA 0 Multi-qualitative Qualitative Qual Form NA NA 0 Issue: 1 Page 7 of 20 Issue date: October 2018

8 Sample VGS Gram Stain Direct Smear 2 x virtual Gram stained slides (A and B). Virtual images of Gram stained smears from various patient sources. Sample GSV Gram Stain Vaginitis 2 x virtual Gram stain slides (A and B). Virtual images of Gram stained patient vaginal smears. Gram Stain Interpretation Microscopic Multiqualitative interpretation and/or quantification Leukocytes Microscopic quantitation Qualitative Stain Quality Microscopic interpretation Qualitative Sputum Specimen Quality Microscopic interpretation Qualitative Bacterial vaginosis Microscopic interpretation Qualitative Nugent Score Quantitative Multiqualitative scoring Sample GBS Group B Strep - molecular 5 x lyophilized swabs (A, B, C, D, and E). Simulated genital samples containing lyophilized bacteria on a swab. Group B Strep Issue: 1 Page 8 of 20 Issue date: October 2018

9 Sample LG Legionella pneumophila Antigen 2 x 0.5ml liquid samples (A and B). Simulated urine samples containing heat inactivated Legionella pneumophila. Legionella pneumophila Antigen Antigen Pos/Neg Sample MRS Methicillin-Resistant Staphylococcus aureus culture 2 x lyophilized swabs (A and B). Simulated patient samples containing lyophilized bacteria on a swab. Methicillin-Resistant Culture isolation Staphylococcus Pos/Neg and aureus culture Sample MRM Methicillin-Resistant/Methicillin-Sensitive Staphylococcus aureus - molecular 2 x lyophilized swabs (A and B). Simulated patient samples containing lyophilized bacteria on a swab. Methicillin-Resistant Staphylococcus aureus Staphylococcus aureus Sample MPM Mycoplasma pneumoniae molecular 2 x 1ml liquid samples (A and B). Simulated nasopharyngeal washings with chemically modified, non-infectious bacterial cells. Mycoplasma pneumoniae Issue: 1 Page 9 of 20 Issue date: October 2018

10 Sample SPN Streptococcus pneumoniae Antigen 2 x 0.5ml liquid samples (A and B). Simulated urine samples containing heat inactivated Streptococcus pneumoniae. Streptococcus pneumoniae Antigen Antigen Pos/Neg Sample SPY Streptococcus pharyngeal - molecular 5 x lyophilized swabs (A, B, C, D, and E). Simulated patient throat swabs containing lyophilized bacteria. Group A Strep Group C/G Strep Sample VRM Vancomycin-Resistant Enterococcus - molecular 2 x lyophilized swabs (A and B). Simulated patient samples containing lyophilized bacteria on a swab. Vancomycin-Resistant Not Enterococcus Detected Sample VRE Vancomycin-Resistant Enterococcus Culture 2 x lyophilized swabs (A and B). Simulated patient samples containing lyophilized bacteria on a swab. Vancomycin- Culture isolation Resistant Pos/Neg and Enterococcus Issue: 1 Page 10 of 20 Issue date: October 2018

11 Mycobacteriology Sample AFB Acid Fast Smears 3 x single-well glass slides (A, B, and C). Formalin fixed bacterial and/or mycobacterial organisms dried on a glass slide. Acid Fast Bacilli Microscopic Pos/Neg Smear interpretation Sample MTM Mycobacterium tuberculosis molecular 2 x 1ml liquid samples (A and B). Simulated sputum samples with chemically modified, noninfectious bacterial cells. Mycobacterium tuberculosis complex Rifampin resistance Sample MTB Mycobacteriology Culture 3 x lyophilized loops and/or liquid samples (A, B, and C). Simulated patient samples from various sources containing mycobacteria in liquid samples and/or lyophilized on loops. Mycobacteriology Culture isolation Multiqualitative culture ID and Issue: 1 Page 11 of 20 Issue date: October 2018

12 Mycology Sample MY Mycology Culture 5 x lyophilized swabs (A, B, C, D, and E). Simulated patient cultures containing fungus, yeast and aerobic actinomycetes lyophilized on swab. Mycology culture ID Culture isolation and Multi-qualitative Parasitology Sample BPS Blood Parasites 3 x Giemsa stained blood smears (A, B, and C); 2 x virtual Giemsa stained blood smears (D and E). Giemsa stained thick and/or thin patient blood smears containing various blood parasites. Blood parasite ID Microscopic Multi-qualitative Sample TCH Trichomonas vaginalis 3 x 2ml liquid samples (A, B, and C). Simulated genital samples in transport media with stabilised microorganisms. Trichomonas Antigen or Pos/Neg vaginalis Issue: 1 Page 12 of 20 Issue date: October 2018

13 Virology Sample HPV Human papillomavirus molecular 5 x 1ml preservative solution with cells containing HPV (A, B, C, D, and E). Simulated cervical samples with chemically modified, non-infectious virus cells. HPV HPV genotyping Multi-qualitative Sample VIR Respiratory Virology 4 x 1ml liquid samples (A, B, C and D). Simulated nasopharyngeal samples containing inactivated virus in storage buffer. RSV Antigen Antigen or Pos/Neg Influenza A Antigen Antigen or Pos/Neg Influenza B Antigen Antigen or Pos/Neg Influenza A or B Antigen or Antigen Pos/Neg Adenovirus Antigen Antigen or Pos/Neg Sample ROT Rotavirus Antigen 3 x 1ml liquid samples (A, B, and C). Simulated faecal samples containing inactivated rotavirus in storage buffer. Rotavirus Antigen Antigen or Pos/Neg Issue: 1 Page 13 of 20 Issue date: October 2018

14 Multiplex Sample BCP Blood Pathogen Panel (multiplex) 5 x 1ml liquid samples (A, B, C, D, and E). Simulated blood cultures with chemically modified, non-infectious bacterial and fungal cells. Acinetobacter sp. Acinetobacter baumannii Citrobacter sp. Enterobacteriaceae Enterobacter sp. Enterobacter cloacae complex Enterococcus sp. Enterococcus faecalis Enterococcus faecium Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Listeria sp. Listeria monocytogenes Neisseria meningitidis Issue: 1 Page 14 of 20 Issue date: October 2018

15 Proteus sp. Pseudomonas aeruginosa Serratia marcescens Staphylococcus sp. Staphylococcus aureus Staphylococcus epidermidis Staphylococcus lugdunensis Streptococcus sp. Streptococcus agalactiae Streptococcus anginosus group Streptococcus pneumoniae Streptococcus pyogenes Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis Resistance Gene: meca Resistance Gene: vana/b Issue: 1 Page 15 of 20 Issue date: October 2018

16 Resistance Gene: vana Not Detected Resistance Gene: vanb Not Detected Resistance Gene: KPC Not Detected Resistance Gene: CTX- Not M Detected Resistance Gene: IMP Not Detected Resistance Gene: NDM Not Detected Resistance Gene: OXA Not Detected Resistance Gene: VIM Sample GIP Gastrointestinal Panel (multiplex) 5 x 1ml liquid samples (A, B, C, D, and E). Simulated faecal samples with chemically modified, non-infectious bacterial and parasitic cells and intact viral particles. Campylobacter sp. C. difficile toxin A/B Enteroaggregative E. coli (EAEC) Enteropathogenic E. coli (EPEC) Enterotoxigenic E. coli (ETEC)lt/st E. coli O157 Plesiomonas shigelloides Issue: 1 Page 16 of 20 Issue date: October 2018

17 Salmonella Shigella Shiga-like toxin producing E. coli (STEC) stx1/stx2 Shigella / Enteroinvasive E. coli (EIEC) Shiga Toxin 1 Shiga Toxin 2 Vibrio Vibrio cholerae Yersinia enterocolitica Cryptosporidium Cyclospora cayetanensis Entamoeba histolytica Giardia lamblia Adenovirus F 40/41 Astrovirus Norovirus GI/GII Rotavirus A Sapovirus Issue: 1 Page 17 of 20 Issue date: October 2018

18 Sample MEP Meningitis Panel (multiplex) 5 x 1ml liquid samples (A, B, C, D, and E). Simulated CSF with chemically modified, noninfectious bacterial and fungal cells and intact viral particles. Escherichia coli K1 Haemophilus influenzae Listeria monocytogenes Neisseria meningitidis Streptococcus agalactiae Streptococcus pneumoniae Cytomegalovirus Enterovirus Herpes simplex virus 1 Herpes simplex virus 2 Human herpes virus 6 Human parechovirus Varicella zoster virus Cryptococcus neoformans/gatti Issue: 1 Page 18 of 20 Issue date: October 2018

19 Sample RSP Respiratory Panel (multiplex) 5 x 1ml liquid samples (A, B, C, D, and E). Simulated nasopharyngeal washings with chemically modified, non-infectious bacterial cells and intact viral particles. Bordetella holmesii Bordetella pertussis B. parapertussis/ bronchiseptica Chlamydophila pneumoniae Mycoplasma pneumoniae Adenovirus Coronavirus Coronavirus 229E Coronavirus HKU1 Coronavirus NL63 Coronavirus OC43 Human Metapneumovirus (hmpv) Human Rhinovirus / Enterovirus Influenza A Influenza A H1 Influenza A H3 Influenza A / H Issue: 1 Page 19 of 20 Issue date: October 2018

20 Influenza B Parainfluenza 1 Parainfluenza 2 Parainfluenza 3 Parainfluenza 4 Respiratory Syncytial Virus RSV A RSV B Rhinovirus Issue: 1 Page 20 of 20 Issue date: October 2018